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NEW YORK (AFX) - Breast implant makers Allergan Inc. and Mentor Corp. said Friday that Canadian regulators have allowed them to put silicone gel breast implants back on the market.
Allergan Inc., also known for its Botox wrinkle treatment, said that Health Canada granted the company a license to sell both its round, smooth and textured silicone implants and Style 410 Shaped and Textured implants. Allergan entered the implant market when it acquired Inamed Corp. earlier in the year.
Mentor said it received a license to sell its round and contour MemoryGel breast implants.
Only saline-filled implants had been allowed on the general market, and silicone implants had only been available through a special access medical device program in Canada.
Under the licenses, breast implant makers must keep providing updates on long-term clinical trial results, report on patient focus groups, begin a large long-term study within one year, survey Canadian doctors on the effectiveness of labeling, and continue implant failure studies, Health Canada said.
Manufacturers must also keep Health Canada up to date on any reported problems or recalls, and provide product registration cards with the implants.
The companies are still awaiting a decision from the Food and Drug Administration concerning the implants.
The FDA banned silicone gel-filled breast implants for cosmetic use more than 14 years ago after thousands of women complained that silicone from leaky or burst implants made them seriously ill.
Allergan shares rose 72 cents to $116.80 and shares of Mentor climbed 27 cents to $47.68 in afternoon trading on the New York Stock Exchange. Copyright 2006 Associated Press. All rights reserved. This material may not be
Copyright 2006 AFX News Limited. All Rights Reserved.
